~34 spots leftby Apr 2026

AFM24 + Atezolizumab for Advanced Cancer

Recruiting in Palo Alto (17 mi)
+16 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Affimed GmbH
Must not be taking: Anticancer, Investigational, Mitomycin, others
Disqualifiers: Active malignancy, Radiation, others
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing AFM24 with atezolizumab in patients with advanced cancers that have not responded to other treatments. The treatment works by helping the immune system recognize and attack cancer cells. Atezolizumab is used in various advanced cancers, including lung and breast cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic anticancer therapy, including investigational agents, at least 4 weeks before starting the study drug. If you are using certain drugs like mitomycin C or nitrosoureas, the period is 6 weeks, and for fluorouracil or small molecule targeted drugs, it's 2 weeks or 5 half-lives, whichever is longer.

What data supports the effectiveness of the drug Atezolizumab in combination with AFM24 for advanced cancer?

Atezolizumab has shown effectiveness in treating various cancers, such as bladder cancer and non-small cell lung cancer, by improving survival rates and response rates in patients. It works by blocking a protein that helps cancer cells hide from the immune system, allowing the body to better fight the cancer.12345

Is the combination of AFM24 and Atezolizumab safe for humans?

Atezolizumab, also known as Tecentriq, has been used in various cancer treatments and generally has an acceptable safety profile. Common side effects include fatigue, decreased appetite, and nausea, while more serious effects can include lung inflammation and liver issues. The safety of AFM24 in combination with Atezolizumab specifically may not be fully established, but Atezolizumab alone has been considered safe in multiple studies.13467

How is the AFM24 + Atezolizumab drug unique for advanced cancer?

The combination of AFM24 and Atezolizumab is unique because it combines a novel treatment (AFM24) with Atezolizumab, a drug that blocks PD-L1, a protein that helps cancer cells evade the immune system. This combination aims to enhance the immune system's ability to fight cancer, offering a potentially new approach for patients with advanced cancer.12358

Research Team

DM

Daniela Morales-Espinosa, MD

Principal Investigator

Affimed GmbH

Eligibility Criteria

This trial is for adults with advanced or metastatic EGFR-positive cancers, like NSCLC, gastric/GEJ adenocarcinoma, HCC, hepatobiliary-, or pancreatic cancer that's worsened after treatment. They must have had certain prior therapies and good organ function. People can't join if they've had recent radiation therapy, active malignancies (with some exceptions), recent anticancer treatments, are using traditional Chinese medicine for tumors, or are in another clinical study.

Inclusion Criteria

I have advanced liver, bile duct, or pancreatic cancer and have tried at least one standard treatment.
My organs are working well.
Phase 1: Evaluable or measurable disease per RECIST v1.1
See 3 more

Exclusion Criteria

I have no active cancers except for certain treated or non-threatening types.
I haven't had radiation therapy in the last 2 weeks or still have side effects from it.
I haven't taken any cancer drugs or traditional Chinese medicine for cancer in the last 2 to 6 weeks.
See 1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Participants receive a single dose of AFM24 and are observed for adverse events for 1 week

1 week

Dose Escalation

Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab using a 3+3 design

Estimated up to 36 weeks

Expansion

Collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab

Estimated up to 36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • AFM24 (Monoclonal Antibodies)
  • Atezolizumab (Checkpoint Inhibitor)
Trial OverviewThe AFM24-102 study tests the combination of a new drug called AFM24 with an existing cancer medication Atezolizumab in patients with specific advanced solid tumors expressing EGFR. It's an open-label Phase 1/2a trial where all participants receive the drugs to evaluate safety and effectiveness at different doses.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Expansion PhaseExperimental Treatment2 Interventions
The expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab.
Group II: Escalation PhaseExperimental Treatment2 Interventions
The Escalation phase will determine the MTD/RP2D of AFM24 in combination with atezolizumab. A traditional 3+3 design will be used to determine the RP2D.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Johns HopkinsBaltimore, MD
Johns Hopkins UniversityBaltimore, MD
USC Norris Comprehensive Cancer CenterLos Angeles, CA
University of Chicago Medical CenterChicago, IL
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Who Is Running the Clinical Trial?

Affimed GmbH

Lead Sponsor

Trials
11
Recruited
650+

Findings from Research

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.
It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.
Atezolizumab: First Global Approval.Markham, A.[2019]
Atezolizumab, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.
In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.
[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma].Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]
Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.
In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.
Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer.Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

References

Atezolizumab: First Global Approval. [2019]
[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. [2019]
Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]
Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer. [2020]
Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. [2020]
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. [2022]
Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]
Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. [2023]